Hepatic Transplantation Registry

NCT ID: NCT05944042

Last Updated: 2024-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2025-02-02

Brief Summary

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The objective is to provide a mechanism to store information regarding the demographic characteristics; pre-, intra-, and post-transplant laboratories; treatment strategies; complications; and outcomes in patients undergoing hepatic transplantation.

Detailed Description

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This study will be conducted at Methodist Dallas Medical Center and include data from hepatic transplant patients beginning in January 2019 and continuing until statistical significance is achieved. Patients will be identified based on ICD-10 procedure codes which are only available post-discharge in the EMR. Data will be collected once patient is discharged and no additional procedures are necessary. All cases meeting the inclusion criteria are expected to be included in this study

Conditions

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Identify More Accurate Predictive Models of Transplant Risk to Monitor and Evaluate New and Existing Patient Factors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Intra-Operative Data:

Intra-Operative Data: Operative time, donor type, transfusions, intraoperative adverse events, mechanical ventilation, portal vein thrombosis, etc.

Observational Transplant Analysis

Intervention Type OTHER

Identify more accurate predictive models of transplant risk

Post-Operative Data and Follow-Up:

Post-Operative Data and Follow-Up: Post-operative laboratories (MELD score, ctDNA, etc.), adverse events, discharge status, hospital length of stay, readmissions, recurrence of primary disease, graft survival, renal disease, post-transplant metabolic syndrome and major cardiovascular events, etc.

Observational Transplant Analysis

Intervention Type OTHER

Identify more accurate predictive models of transplant risk

Interventions

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Observational Transplant Analysis

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Intervention Type OTHER

Other Intervention Names

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Predictive models of transplant usage

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years Submitted to hepatic transplantation (Current Procedural Terminology® code 47135
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Methodist Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Methodist Dallas Medical Center

Dallas, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Colette N Ndjom, MS

Role: CONTACT

214-947-1280 ext. 74681

Loretta W Bedell, MPH

Role: CONTACT

214-947-4681 ext. 74681

Facility Contacts

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Colette N Ndjom, MS

Role: primary

214-947-4680 ext. 71280

Loretta W Bedell, MPH

Role: backup

217-947-4681 ext. 74681

References

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Jadlowiec CC, Taner T. Liver transplantation: Current status and challenges. World J Gastroenterol. 2016 May 14;22(18):4438-45. doi: 10.3748/wjg.v22.i18.4438.

Reference Type BACKGROUND
PMID: 27182155 (View on PubMed)

Zimmerman MA, Ghobrial RM, Tong MJ, Hiatt JR, Cameron AM, Hong J, Busuttil RW. Recurrence of hepatocellular carcinoma following liver transplantation: a review of preoperative and postoperative prognostic indicators. Arch Surg. 2008 Feb;143(2):182-8; discussion 188. doi: 10.1001/archsurg.2007.39.

Reference Type BACKGROUND
PMID: 18283144 (View on PubMed)

Other Identifiers

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002.HPB.2023.D

Identifier Type: -

Identifier Source: org_study_id

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